Nonin NoninConnect Elite 3240 Instructions For Use

Instructions for Use – English
NoninConnect Elite™ Model 3240
®
Bluetooth Smart Pulse Oximeter
0123 0123
Installing AAA Batteries Turning On the NoninConnect
Elite Model 3240
WARNING: Before changing
1. Insert a digit into the Model 3240
batteries, make sure the device is
until it touches the built-in stop.
off and is not applied to a digit.
1. Hold the 3240 so you see the
back of the device and the
arrows on the battery door
point away from you.
.
2. Place your thumbs on the ovals.
NOTE: Make sure the finger is lying
3. Slide the battery door away
from you and off the 3240. flat (not on its side) and is centered
within the device. For best results,
keep the device at heart or chest
level.
2. If the CorrectCheck screen
(see Display Symbols table)
displays, slide finger further
into device. Correct positioning
of the finger is critical for
accurate measurements.
3. The 3240 begins sensing the
pulse and displaying readings.
4. If applicable, remove the
old batteries from the 3240.
Properly dispose of the
batteries.
5. Insert two new 1.5 volt AAA-
size batteries. Carefully match
the polarity markings (+ and -).
The 3240 will not work if the
batteries are inserted the
wrong way.
4. View about 4 seconds of
readings before relying on the
displayed values. It is common
for the displayed values to vary
slightly over a period of
several seconds.
NOTE: While on the finger, do
not press the device against any
surface and do not squeeze or hold
it together. The internal spring
provides the correct pressure;
additional pressure may cause
inaccurate readings.
6. Carefully slide the battery door
back onto the device.
Nonin Medical, Inc. +1 (763) 553-9968 Fax: +1 (763) 553-7807
13700 1st Avenue North (800) 356-8874 (US and Canada) +31 (0)13 - 79 99 042 (Europe)
Plymouth, MN 55441-5443 USA +31 (0)13 - 79 99 040 (Europe)
E-mail: info@nonin.com
nonin.com infointl@nonin.com (Europe)
Indications for Use
The NoninConnect Elite Model 3240 Finger Pulse Oximeter is a small, lightweight, portable device
indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin
(%SpO ) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of
2
adult and pediatric patients with digits between 0.8 – 2.5 cm (0.3 – 1.0 inch) thick.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed
practitioner.
NOTE: Use Environment—Home healthcare environments under the supervision of qualified medical
professionals. Users include current/potential users of pulse oximetry in the home and caregivers/
potential caregivers of such a user.
Contraindications
Do not use the device in an MR environment, in an explosive atmosphere, or on neonatal patients.
MR MR
• This device is not defibrillation proof per IEC 60601-1.
Warnings
• Use the Model 3240 within its designated range (approximately 10 m/32 ft, spherical radius, line of sight
when connected to a Bluetooth Smart Ready device). Moving outside this range may cause missing, lost,
and/or inaccurate data.
• Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and
skin integrity. Patient sensitivity to sensor may vary due to medical status or skin condition.
• Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
• This device is intended only as an adjunct in patient assessment. It must be used in conjunction with
other methods of assessing clinical signs and symptoms.
• The device must be able to measure the pulse properly to obtain an accurate SpO
2
that nothing is hindering the pulse measurement before relying on the SpO measurement.
2
• Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
• General operation of the device may be affected by the use of an electrosurgical unit (ESU).
• Keep the oximeter away from young children. Small items such as the battery door and battery are
choking hazards.
• Before changing batteries, make sure the device is off and is not applied to a digit.
Cautions
• This device has no audible alarms and is intended only for spot-checking.
• This device is designed to determine the percentage of arterial oxygen saturation of functional
hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the
measurement include the following:
• applying the pulse oximeter on • improperly applied device • anemia or low hemoglobin
the same arm as a blood • finger is outside recommended concentrations
pressure cuff, arterial catheter size range • carboxyhemoglobin
or infusion line(s) (IVs) • poor pulse quality • methemoglobin
• excessive light, such as sunlight • venous pulsations • dysfunctional hemoglobin
or direct home lighting • cardiogreen and other • artificial nails or fingernail
• excessive motion intravascular dyes polish
• moisture in the device
• The device may not work when circulation is reduced. Warm or rub the finger, or re-position the device.
• The device is designed to be attached only to a digit.
• This device's display will shut off after 30 seconds of no readings or poor readings.
• In some circumstances, the device will interpret motion as good pulse quality. Minimize patient motion
as much as possible.
• Clean the device before applying it to a new patient.
• Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids into the device.
• Do not use caustic or abrasive cleaning agents, or any cleaning products containing ammonium chloride
or isopropyl alcohol.
• Do not use cleaning solutions other than those recommended here, as permanent damage could result.
• This device is a precision electronic instrument and must be repaired by qualified technical
professionals. Field repair of the device is not possible. Do not attempt to open the case or repair the
electronics. Opening the case may damage the device and void the warranty.
• This equipment complies with IEC 60601-1-2 for electromagnetic compatibility for medical electrical
equipment and/or systems. This standard is designed to provide reasonable protection against harmful
interference in a typical medical installation. However, because of the proliferation of radio-frequency
transmitting equipment and other sources of electrical noise in health care and other environments, it is
possible that high levels of such interference due to close proximity or strength of a source might disrupt the
performance of this device. Medical electrical equipment needs special precautions regarding EMC, and all
equipment must be installed and put into service according to the EMC information specified in this manual.
• Portable and mobile RF communications equipment including CT, diathermy, RFID, and electronic
article security systems can affect medical electrical equipment.
• Batteries may leak or explode if used or disposed of improperly. Remove batteries if the device will be stored
for more than 30 days. Do not use different types of batteries at the same time. Do not mix fully charged and
partially charged batteries at the same time. These actions may cause the batteries to leak.
• Follow local, state, and national governing ordinances and recycling instructions regarding disposal or
recycling of the device and device components, including batteries.
• In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/
96/EC, do not dispose of this product as unsorted municipal waste. This device contains WEEE materials;
please contact your distributor regarding take-back or recycling of the device. If you are unsure how to
reach your distributor, please call Nonin for your distributor's contact information.
Symbols
Symbol Definition Symbol Definition
Not for continuous monitoring (no
Caution!
! alarm for SpO )
2
Follow Instructions for Use. Battery orientation
Protected against vertically falling
Consult Instructions for Use.
water drops when enclosure is tilted up
to 15 degrees and ingress of solid
MR unsafe
IP32
MR MR
foreign objects greater than or equal to
Type BF Applied Part (patient isolation
2.5 mm (0.1 in.) in diameter per
from electrical shock) IEC 60529.
UL Mark for Canada and the United SN Serial Number
States with respect to electric shock,
BDA Bluetooth Device Address
fire, and mechanical hazards only in
accordance with IEC 60601-1,
Storage/shipping temperature range of
+70°C
UL 60601-1 and CAN/CSA-C22.2
-40 °C to 70 °C (-40 °F to 158 °F)
No. 601.1.
-40°C
CE Marking indicating conformance
to EC Directive No. 93/42/EEC Handle with care
0123 0123
concerning medical devices.
Radio Equipment Class Identifier Keep dry
Non-ionizing electromagnetic Indoor use (France only)
radiation. Equipment includes RF
transmitters. Interference may occur in Medical prescription required
the vicinity of equipment marked with
Manufacturer
this symbol.
Authorized EC Representative: 11038-001-01
MPS, Medical Product Service GmbH ©2015 Nonin Medical, Inc.
Borngasse 20
Nonin, NoninConnect Elite, and CorrectCheck are trademarks of Nonin Medical, Inc.
D-35619 Braunfels, Germany
U.S. Patents 5,490,523; 5,792,052; other patents pending.
Symbol Definition Symbol
Indicates separate collection for
electrical and electronic equipment
(WEEE)
NOTE: Where applicable, an additional label bearing your country radio communications license
information will appear on the side of your device. This is not a serial number or device identifier.
Display Symbols
Symbol Description
Nonin's CorrectCheck™ senses that the finger has not been correctly inserted. If
you see this symbol, slide finger further into device.
The number next to this symbol is the amount of oxygen in your blood (functional
oxygen saturation of arterial hemoglobin).
The number next to this animated symbol is your pulse rate. Pulse rate is the
number of times your heart beats per minute.
– – – Dashes replace the readings when the 3240 is unable to detect a usable signal.
White symbol – Radio is on.
Green symbol – 3240 is connected.
Flashing white symbol – Connection error. The radio will reset.
measurement. Verify
Poor signal. Steady your hand, reposition finger, warm finger by rubbing, or select
a different finger.
Low battery. Replace batteries.
Critical battery. Flashing indicator on full screen. The device will not work until the
batteries are replaced.
Using the NoninConnect Elite Model 3240
Installing AAA Batteries
Use only alkaline batteries. When batteries are low, displays. Replace low batteries as soon as possible.
See the "Installing AAA Batteries" instructions and figures at left.
Turning On the NoninConnect Elite Model 3240
See the "Turning on the NoninConnect Elite Model 3240" instructions and figures at left.
Connection via Bluetooth Wireless Technology
When the Model 3240 is placed on the finger and turns on, it is ready for a Bluetooth wireless connection.
The 3240 stays in this mode until it is shut off. The symbol is white when the Bluetooth radio is on, green
when the 3240 is connected, and flashes white when there is a communication error.
The Bluetooth symbol is useful for the product installer.
Due to the wide variety of wireless environments, the Bluetooth connection between the 3240 and the host
device must be tested before using the 3240's Bluetooth capabilities.
Turning Off the NoninConnect Elite Model 3240
The Model 3240 will automatically turn off approximately 10 seconds after the digit is removed, or after
a 2-minute period of poor signals.
Cleaning the NoninConnect Elite Model 3240
CAUTIONS:
!
• Clean the device before applying it to a new patient.
• Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids into
the device.
• Do not use caustic or abrasive cleaning agents, or any cleaning products containing ammonium chloride
or isopropyl alcohol.
• Do not use cleaning solutions other than those recommended here, as permanent damage could result.
1. To clean, wipe the device's surfaces with a soft cloth dampened with one of the following:
• A 10% bleach solution (household bleach [5.25% sodium hypochlorite]).
• Warm, soapy water (hand dishwashing detergent – see note below), and then rinse the cleaned
surfaces with a soft cloth dampened with water (home use only).
2. Dry with a soft cloth, or allow to air dry. Ensure that all surfaces are completely dry.
NOTE: The hand dishwashing detergent that was tested includes these ingredients: Sodium Lauryl
Sulfate, Sodium Laureth Sulfate, Lauramine Oxide, Sodium Chloride, PPG-26, PEG-8 Propylheptyl
Ether, and Phenoxyethanol.
Warranty
NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of 2 years
from the date of purchase, each Model 3240 exclusive of the batteries and spring. The device's expected
service life is 5 years.
Nonin shall repair or replace any 3240 found to be defective in accordance with this warranty, free of
charge, for which Nonin has been notified by the purchaser by serial number that there is a defect,
provided notification occurs within the applicable warranty period. If unable to repair, Nonin shall replace
with a 3240 or a comparable device. This warranty shall be the sole and exclusive remedy by the purchaser
hereunder for any 3240 delivered to the purchaser which is found to be defective in any manner whether
such remedies be in contract, tort or by law.
This warranty excludes cost of delivery to and from Nonin. All repaired units shall be received by the
purchaser at Nonin's place of business. Nonin reserves the right to charge a fee for a warranty repair
request on any 3240 found to be within specifications.
Model 3240 is a precision electronic instrument and must be repaired by trained Nonin personnel only.
Any sign or evidence of opening the 3240, field service by non-Nonin personnel, tampering, or any kind
of misuse of the 3240, shall void the warranty. All non-warranty work shall be done at Nonin's standard rates
and charges in effect at the time of delivery to Nonin.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA
(800) 356-8874 (USA/Canada)
+1 (763) 553-9968 (outside USA and Canada)
Fax: +1 (763) 553-7807
E-mail: technicalservice@nonin.com
nonin.com
Specifications
Definition
Oxygen Saturation Display Range:
Authorized Representative in the
Pulse Rate Display Range:
EC REP European Community
Declared Accuracy*:
Catalogue number
REF REF
NOTE: If your national regulatory authority recognizes accuracy in motion, please contact
regulatory@nonin.com for accuracy data.
Specified Oxygen
Range
Saturation (A
70 – 100% ± 2
70 – 80% ± 2
80 – 90% ± 2
90 – 100% ± 2
Bias=0
Limits of Agreement
Linear Regression
9
13
13 9
3
3
8 13
8
13 8
13 9
8 9 14
13 8 3 3
9
8 8 8 8 3 14
8 13
8 12 12 13 13 3
2 14
8 8 12 8 9 14 2 14
12 4 8 14 13 14
11 8 3 8 14 13
4 4 12 13 6
12 8 12 12 2 2 13 4
8 12 8 4 2 13
12 8 14 11
4 8 12 12 12 11
4 12 12 4 2 14 13 13
11 2 12 4 4 14 14 8 11 11 8 6
11 4 4 8 8 8 3 14
11 4 8 2 12 14 11 12 14 6 13 13 4
4 6 6 8 2 8 7 12 6 14
12 4 8 12 5 11 3 4
6 12 12 12 2 2 7 5 2 14 3 11
11 4 4 4 2 2 7 14 3 14 13 13
11 11 4 12 8 11 7 3 12
11 11 11 6 7 2 5 12 11 12
6 7 2 2
6 12 5 5
11 11 11 12
12 7 2 7 7
12
11 4 2
7
14
2 4
4
11
5
70 75 80
Pulse Rate Declared Accuracy Range (A
Low Perfusion Pulse Rate Declared Accuracy Range (A
Measurement Wavelengths and Output Power**:
Red.
Infrared.
Temperature:
Operating.
Storage/Transportation.
Humidity:
Operating.
Storage/Transportation.
Altitude:
Operating.
Hyperbaric Pressure.
Battery Life:
Operating.
Storage.
* ±1 A represents approximately 68% of measurements.
rms
** This information is especially useful for clinicians performing photodynamic therapy.
Bluetooth Wireless Technology Information
Bluetooth Compliance:
Operating Frequency:
Output Power:
Operating Range:
Network Topology:
Operation:
Antenna Type:
Modulation Type:
Data Rate:
Data Latency:
Data Integrity:
Data Format:
Quality of Service:
Bluetooth Profiles Supported:
Authentication and Encryption:
Encryption Key Size:
®
The Bluetooth word mark and logo are registered trademarks owned by Bluetooth SIG, Inc.
Bluetooth Security
The Bluetooth radio contained in the 3240 is a Bluetooth Smart single-mode, low-energy radio. It supports
a GATT-based, proprietary Nonin profile to transmit current readings from the patient. Data is not stored
by the 3240 to be transferred at a later time. The 3240 supports an encryption key size of 128 bits. While
Nonin Medical B.V.
the 3240 is in a Bluetooth connection, it will be unavailable for other connections. Apart from the standard
Prins Hendriklaan 26
Bluetooth security measures, Nonin has implemented a non-standard security measure to the 3240 that, if
1075 BD Amsterdam, Netherlands
used, will restrict the transfer of data to only devices with a specified organizationally unique identifier
+31 (0)13 - 79 99 040 (Europe) (OUI).
Fax: +31 (0)13 - 79 99 042
For additional technical information, please see the insert, "NoninConnect Elite Model 3240 Technical
E-mail: technicalserviceintl@nonin.com
Description."
0% to 100% SpO
2
18 to 321 beats per minute (BPM)
The table below shows A values measured using the Model 3240 in a
rms
clinical study.
Accuracy Summary – Finger and Thumb
Thumb Oxygen Low Perfusion
Finger Oxygen
) Saturation (A ) Oxygen Saturation (A )
Saturation (A )
rms rms rms
rms
± 1.56 ± 2
± 1.31
± 1.65 ± 1.91 ± 2
± 1.21 ± 2
± 1.05
± 1.49 ± 2
± 1.18
This graph shows plots of the
error (SpO – SaO ) by SaO
2 2 2
using the 3240 with a linear
regression fit and upper 95% and
lower 95% limits of agreement.
Each sample data point is
10 identified by subject from a
6
14
14
10 10 14 10 10
6 6
14 10 12 clinical study in non-motion
4 12 4 9
8 4 10 14 14 14 4 9
14 14 9 3 12 6
3 4 10 14 8 12 4 7 7 7 7 4 6 9
8 11 11 9 7 9 7 14 8 8 3 9 7 7
8 4 7 7 9 12 7 7 3 9 3 3 conditions.
7 12 7 7 8 12 9
12 10 10 8 8 14 9 9 12 12 14 2 3
13 14 8 3 12 4 4 4 7 3 6 2 6 9
13 8 7 11 6 6 3 9 3 3 9 11 3 3 3
12 12 3 11 2 9
12 9 7 7 12 5 11 5 7 7 10 7 11 6 3 2
3 12 7 9 7 8 6 11 11 6 9 3
13 4 12 11 3 3 11 3 33 9
8 3 13 11 12 3 11 9
13 13 13 4 4 11 9 2 3 3 6 2
14 4 12 14 10 11 9 10 11 4 14 5 5
13 13 13 6 3 2 3 14 3 10 6
8 5 5 5 5 5 5 14 12 13 10 11 11 9 11 8 2 14 5 5 5 5 5 5
4 8 13 2 3 3 14 10 2
11 11 13 11 5 14 5 5
4 3 5 8 5 5 14 13 8 8 13 13
8 8 8 5 5 5 14
3 2 14 3 14 8 13 13 13
2 5 13 13 5 5 13
5 6 2 13 5
5 5 13
4 8
4 5 5 4 2 2 2 13 13 2
4
2 4 2 2
2
2
2 2 4
Finger
Thumb
85 90 95 100
SaO (%)
2
)*: 20 to 250 BPM ±3 digits
rms
)*: 40 to 240 BPM ±3 digits
rms
660 nanometers @ 0.8 mW max. average
910 nanometers @ 1.2 mW max. average
-5 °C to 40 °C / 23 °F to 104 °F
-40 °C to 70 °C / -40 °F to 158 °F
10% to 95% non-condensing
10% to 95% non-condensing
Up to 10,000 meters / 32,808 feet
Up to 4 atmospheres
Approximately 2,200 spot checks (25 sec. per spot-check), within 10
meters/32 feet of collector with streaming data
1 month, with batteries installed. CAUTION: Remove batteries if the
device will be stored for more than 30 days.
Version 4.0 single mode low energy
2.4 to 2.4835 GHz
TX: +3 dBM
10 meter radius (line of sight)
Star - bus
Slave
Model 3240
Integrated chip type antenna
Frequency Hopping Spread Spectrum
1 Mbit/second
6 ms
Adaptive Frequency Hopping
24-bit CRC (cyclic redundancy check)
32-bit message integrity check
Sends data packets once per second. Includes a second counter that
allows the host to detect if packets are missing and the device to
retransmit.
This device uses Bluetooth Smart technology for wireless
communications, which allows for reliable communications in
electrically noisy environments, and transmits physiological data once
per second. If data is lost, the device will transmit data again one second
later. If the connection is lost, the device will change the Bluetooth symbol
from green to white and become available for a connection in a few
seconds.
GATT-based proprietary Nonin profile
Supported
128 bits AES (advanced encryption standard)